NDC 68012-309

Uceris

Budesonide

Uceris is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Santarus Inc.. The primary component is Budesonide.

• Product ID: 68012-309_22da619a-1ffe-4f44-914c-1444be7ce6ef
• NDC: 68012-309
• Product Type: Human Prescription Drug
• Proprietary Name: Uceris
• Generic Name: Budesonide
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-14
• Marketing Category: NDA / NDA
• Application Number: NDA203634
• Labeler Name: Santarus Inc.
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 9 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68012-309-01

2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)

• Marketing Start Date: 2013-01-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68012-309-02 [68012030902]

Uceris TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA203634
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-14

NDC 68012-309-01 [68012030901]

Uceris TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA203634
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-14

NDC 68012-309-30 [68012030930]

Uceris TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA203634
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-14

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	9 mg/1

OpenFDA Data

• SPL SET ID: 92cbb190-8851-46ed-bfe0-166ca62ef2e9
• Manufacturer:
  • Santarus Inc.
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1366556
  • 1366550

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

68012030930 UCERIS 9 MG ER TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Uceris" or generic name "Budesonide"

NDC	Brand Name	Generic Name
68012-309	Uceris	Uceris
65649-651	Uceris	Uceris
0093-6815	Budesonide	Budesonide
0093-6816	Budesonide	Budesonide
0093-6817	Budesonide	Budesonide
0093-7445	Budesonide	Budesonide
0115-1687	Budesonide Inhalation	Budesonide
0115-1689	Budesonide Inhalation	Budesonide
0186-0916	PULMICORT	Budesonide
0186-0917	PULMICORT	Budesonide
0186-1988	PULMICORT RESPULES	Budesonide
0186-1989	PULMICORT RESPULES	Budesonide
0186-1990	PULMICORT RESPULES	Budesonide